An Impact Assessment of a Culturally Tailored Online Psychosocial Program for Chinese Immigrant Women With Breast Cancer

NCT04656353 | Completed

• 1 other identifier: 20-5215.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effectiveness of an online psychosocial self-help program for Chinese immigrant women with breast cancer, by comparing Chinese immigrant women who receive the online psychosocial program and those who do not receive the program. The investigators want to understand if this online psychosocial program is effective in helping Chinese immigrant women to feel more supported, understand that the distress is normal, engage in self-care activities, become aware of the community resources, feel more confident about returning to a normal life, and feel less distress overall as they return to life after treatment. This information will help us to better understand these Chinese immigrant women's needs and concerns and plan future growth of the program to meet their personal, cultural, and language needs.

Conditions

Breast Cancer

Keywords

Breast cancer; Chinese women; psychosocial; online program

Outcome Measures

Primary Outcomes (4)

• Changed feelings of support

  A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  Baseline, 2 weeks and 3-month periods

• Changed feelings of their distress as normal

  A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  Baseline, 2 weeks and 3-month periods

• Changed awareness of self-care activities and resources

  A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  Baseline, 2 weeks and 3-month periods

• Changed confidence about returning to a normal life post-treatment

  A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  Baseline, 2 weeks and 3-month periods

Secondary Outcomes (1)

• Changed emotional distress

  Baseline, 2 weeks and 3month periods

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants randomized to the Intervention Arm will be provided with the website link to the online psychosocial program and the questionnaire and distress survey. They will be asked to use the website within two weeks and then to complete the questionnaire and distress survey after using it and mail them back in a self-addressed stamped envelope. The participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted.

Behavioral: Intervention Arm

Control Group

EXPERIMENTAL

Participants randomized to the Control group will receive standard care (no intervention). They will be used as a baseline to compare groups and assess the effect of the intervention (i.e., the online psychosocial program). At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), they will be asked to complete the questionnaire and distress survey and return them in a self-addressed stamped envelope. Participants will be given two weeks to complete the questionnaire and distress survey. The same documents will be administered at the 3-month follow-up period (T2). Once the 3-month follow-up is completed, each participant will be provided with the website link to view the self-help program.

Behavioral: Control Group

Interventions

Intervention Arm BEHAVIORAL

Participants randomized to the Intervention Arm will be provided with the website link to the online self-help program and a questionnaire and a distress survey. They will be asked to use the website within two weeks and then to complete these documents after using it and mail them back in a self-addressed stamped envelope. Same documents will be administered at the 3-month follow-up period, and the participant will be given two weeks to complete and return it in a self-addressed stamped envelope. Additionally, participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted. The focus groups will last about 1-1.5 hours and consist of 3-4 participants. Focus groups will be audio-taped and conducted in either English or Chinese.

Intervention Arm

Control Group BEHAVIORAL

Participants randomized to the Control group will receive standard care (no intervention). They will be used as a baseline to compare groups and assess the effect of the intervention (i.e., the online psychosocial program). At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), they will be asked to complete the questionnaire and distress survey and return them in a self-addressed stamped envelope. Participants will be given two weeks to complete the questionnaire and distress survey. The same documents will be administered at the 3-month follow-up period (T2). Once the 3-month follow-up is completed, each participant will be provided with the website link to view the self-help program.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Foreign-born Chinese immigrant women who identify their mother tongue as either Cantonese or Mandarin
• A diagnosis of new breast cancer (Stages 0-III)
• Receiving surgery (i.e., mastectomy) or adjuvant radiation therapy as the last hospital-based treatment, with the exception of Tamoxifen, bisphosphonates, and Herceptin
• Able to use a computer
• Able to read and speak English, Cantonese, or Mandarin.

You may not qualify if:

• recurrence or metastatic disease

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2C1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Terry Cheng

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)